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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-SC240085 | Registry Identifier | CDMRP-eBRAP Log Number |
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| Name | Class |
|---|---|
| Congressionally Directed Medical Research Programs | FED |
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The purpose of this study is to determine the safety and efficacy of Injectrode Tibial Nerve Stimulation for bladder function in people with spinal cord injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral iTNS | Experimental | participants will receive one active tibial nerve stimulation (TNS) device and both legs will receive active stimulation |
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| Unilateral iTNS | Active Comparator | participants will receive one active and one sham tibial nerve stimulation (TNS) device. The treatment will only be delivered to the leg with the active device. |
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| Sham iTNS | Sham Comparator | participants will receive one one sham tibial nerve stimulation (TNS) device for bilateral use. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iTNS | Device | The stimulation current will be gradually increased until bilateral toe flexion is achieved, then reduced to just below the motor contraction threshold. A 20 Hz frequency and 200 µs pulse width will be applied continuously for 30 minutes, five times a week. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as assessed by the number of device-related adverse events | Adverse events include lead migration and fracture, hematoma, wound infection, delayed healing, nerve injury, and autonomic dysreflexia occurrence during the procedure. | From baseline to 8 weeks |
| Accuracy as assessed by the percentage of sessions where toe flexion was achieved as recorded in subject logs. | From baseline to week 8 | |
| Reliability as assessed by the average minimum current (mA) required to elicit toe flexion when testing for accuracy | From baseline to week 8 | |
| Feasibility of Injectrode procedure as assessed by surveys | Feasibility to check if reproducible training pathway can enable non-interventional physicians to competently perform Injectrode implantation and removal | Week 8 |
| Physician acceptability of Injectrode device as assessed by a survey | The acceptability survey ranges from 0 - 32, with a higher score indicating greater acceptability of the Injectrode device. | Week 8 |
| Participant acceptability of Injectrode device as assessed by a survey | The acceptability survey ranges from 0 - 25, with a higher score indicating greater acceptability of the Injectrode device. | Week 8 |
| Feasibility and acceptability of the Injectrode treatment as assessed by a qualitative interview | A semi-structured interview will be conducted with participants and providers to explore their perceptions of the Injectrode treatment. Responses will be summarized using qualitative coding and descriptive statistics of themes. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants for whom bladder medication dosage reduced | from baseline to 8 weeks | |
| Change in magnitude of dosage of medication | from baseline to 8 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Argyrios Stampas, MD | Contact | (713) 797-5938 | argyrios.stampas@uth.tmc.edu | |
| Danira Garcia Gutierrez | Contact | (713) 797-7133 | Danira.GarciaGutierrez@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Argyrios Stampas, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D001750 | Urinary Bladder, Neurogenic |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Sham iTNS | Device | The sham devices are designed to mimic active stimulation by initially delivering electrical current sufficient to evoke toe flexion. However, once the current is reduced to the sensory stimulation threshold, the device automatically ramps down to 0mA while maintaining the appearance of normal functioning on the display screen. |
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| Week 8 |
| Change in bladder function during urodynamics as assessed by the maximum detrusor pressure (Max Pdet) in cmH20. |
| Baseline, Week 4, and Week 8 |
| Change in Bladder function as assessed by the presence or absence of detrusor overactivity (DO) during urodynamics. | baseline, Week 4, and Week 8 |
| Change in bladder capacity (maximum volume in mL) during urodynamics before voiding or discomfort. | baseline, Week 4, and Week 8 |
| Change in the presence or absence of leaks during urodynamics. | baseline, Week 4, and Week 8 |
| Change in bladder sensation during urodynamics as defined by the infused volume (mL) at time of reported first sensation of filling. | baseline, Week 4, and Week 8 |
| Change in bladder sensation during urodynamics as defined by infused volume (mL) at time of reported urgency/ desire to void. | Baseline, Week 4, and Week 8 |
| Change in bladder sensation during urodynamics as defined by the infused volume (mL) at the time of reported discomfort. | Baseline, Week 4, and Week 8 |
| Change in detrusor compliance during urodynamics as reported by the change in bladder volume divided by the change in bladder pressure. | baseline, Week 4, and Week 8 |
| Change in the number of incontinence episodes as self-reported in the bladder diary. | Baseline, Week 4, and Week 8 |
| Change in the frequency of catheterization as self-reported in the bladder diary. | Baseline, Week 4, and Week 8 |
| Change in the volume of catheterization as self-reported in the bladder diary. | Baseline, Week 4, and Week 8 |
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |